Ovine derived human TNFα polyclonal antibody composition for oral administration

Abstract

The present invention is directed to an antibody composition for oral administration comprising intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor α (TNFα), and means for protecting the antibodies during gastrointestinal transit, as well as methods for manufacturing, kits, and therapeutic uses of the same.

The invention claimed is: 
     
       1. An antibody composition for oral administration comprising:
 a. intact blood-derived polyclonal antibodies that bind to a human tumour necrosis factor a (TNFα); and 
 b. a protease inhibitor and/or an antacid, 
 
       wherein the intact blood-derived polyclonal antibodies are derived from serum or plasma of an ovine mammal administered TNFα or a fragment thereof. 
     
     
       2. The antibody composition of  claim 1 , wherein the antibody composition and the intact blood-derived polyclonal antibodies therein have not been affinity purified. 
     
     
       3. The antibody composition of  claim 1 , wherein the intact blood-derived polyclonal antibodies are purified using sodium sulphate precipitation or caprylic acid precipitation, and optionally, filtration. 
     
     
       4. The antibody composition of  claim 1 , wherein the protease inhibitor is selected from the Bowman-Birk inhibitor family of proteins. 
     
     
       5. The antibody composition of  claim 1 , wherein the protease inhibitor comprises one or more of:
 a. a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin; and/or b. an antibody that binds to trypsin and/or chymotrypsin and suppresses or inactivates the protease activity of said trypsin and/or chymotrypsin. 
 
     
     
       6. The antibody composition of  claim 1 , wherein the protease inhibitor comprises egg whites. 
     
     
       7. The antibody composition of  claim 6 , wherein the egg whites comprise powdered egg whites. 
     
     
       8. The antibody composition of  claim 1 , wherein the protease inhibitor comprises ovomucoid, ovostatin, ovomacroglobulin, or combinations thereof. 
     
     
       9. The antibody composition of  claim 1 , formulated as a liquid. 
     
     
       10. The antibody composition of  claim 1 , wherein at least 5% of the total antibodies present in the composition bind to TNFα. 
     
     
       11. The antibody composition of  claim 1 , wherein at least 10% of the total antibodies present in the composition bind to TNFα. 
     
     
       12. A method for manufacturing an antibody composition for oral administration, said method comprising:
 a. obtaining a blood sample from an ovine mammal that has been administered an immunogen comprising human tumour necrosis factor a (TNFα) or a fragment thereof, thereby providing a sample comprising intact blood-derived polyclonal antibodies that bind to TNFα; 
 b. admixing the intact blood-derived polyclonal antibodies that bind to human TNFα with a protease inhibitor and/or an antacid. 
 
     
     
       13. The method of  claim 12 , wherein the obtaining further comprises obtaining serum from the blood sample.